2005D-0330 Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
FDA Comment Number : EC4
Submitter : Mr. Jim Matrisciano Date & Time: 12/22/2005 05:12:05
Organization : Bergen Community Regional Blood Center
Category : Health Care Association
Issue Areas/Comments
GENERAL
GENERAL
I am the VP of Operations for Bergen Community Regional Blood Center dba Community Blood Services in Paramus NJ 07653. I would like to see the following in relation to the draft guidance:
1) An extension on the 01-03-06 deadline.
2) A public hearing to discuss these issues whereby experts could provide their insights and testimony.
3) Limiting donors to 24 therapeutic doses per year as opposed to 24 collections will severely impact our collections and send a confusing message to our donors.
4) Emergency Response Personnel - not logistically possible to have our Medical Director on site for each collection. Currently within 15 minutes of each collection site by telephone and will have our staff trained in determining when to call 911 for medical assistance.
5)Aspirin deferral - keep to 3 days which is AABB standard.
6)Limits of total volume of products removed - keep at 1500 ml/yr.
7)Multiple venipunctures - maintain for single vein access machines as opposed to single attempt.
8)WBC Residual Count - maintain at 6 per month for each SDP product.